E4300 Basic Surgical Pack 3-Laminate E4300

GUDID 00816953027434

Surgical gown, single-use

Primary Device ID	00816953027434
NIH Device Record Key	7e35de48-7bf6-458e-8718-6fdacf5b0759
Commercial Distribution Status	In Commercial Distribution
Brand Name	E4300 Basic Surgical Pack 3-Laminate
Version Model Number	E4300
Catalog Number	E4300
Company DUNS	014464314
Company Name	EXACT MEDICAL MANUFACTURING, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00816953027434 [Primary]

FYA	Gown, Surgical

Steralize Prior To Use	false
Device Is Sterile	true

26975424195848 - Exact Medical Manufacturing, Inc.	2025-04-03 Incise Drape, 16x19cm, Adhesive Area 10x19cm
26975424195855 - Exact Medical Manufacturing, Inc.	2025-04-03 Incise Drape 45cm x 55cm - 18" x 22"
26975424195862 - Exact Medical Manufacturing, Inc.	2025-04-03 Fenestrated Drape with Linear Tear Technology - 89x127cm
26975424195879 - Exact Medical Manufacturing, Inc.	2025-04-03 Ophthalmic Full Body Drape 183cm x 292cm - 72" x 115"
26975424195886 - Exact Medical Manufacturing, Inc.	2025-04-03 Two-Tier Backtable Cover HD 183cm - 72"
16975424195940 - Exact Medical Manufacturing, Inc.	2025-04-03 Ivoclar Cover with Elastic bands, folded
16975424195964 - Exact Medical Manufacturing, Inc.	2025-04-03 Probe Cover, PE,Tape tip,Gel & Elastic bands 18x28cm-7"x11"
16975424195971 - Exact Medical Manufacturing, Inc.	2025-04-03 Probe Cover (Flat End) W/Gel & Bands 5.5" x 48"